Balloon expandable endoprosthesis

ABSTRACT

An improved medical device reduces the loss of longitudinal length during expansion of a stent-graft from a compressed state to an expanded state. For example, the stent-graft is placed over a cover that provides resistance to expansion of the balloon during inflation, which reduces longitudinal compressing forces exerted on the stent-graft.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/444,725, filed Jun. 18, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/531,252, filed May 26, 2017, now U.S. Pat. No.10,543,116, issued Jan. 28, 2020, which is a 371 National PhaseApplication of PCT/US2015/062799, filed Nov. 25, 2015. U.S. applicationSer. No. 15/531,252 is also a continuation of U.S. patent applicationSer. No. 14/950,165, filed Nov. 24, 2015, now U.S. Pat. No. 10,299,948,issued May 28, 2019, which claims the benefit of U.S. ProvisionalApplication 62/085,066, filed Nov. 26, 2014. All of the aboveapplications are incorporated herein by reference in their entiretiesfor all purposes.

FIELD

The present disclosure generally relates to endoprostheses for treatingvasculature, and more particularly, to balloon expandable endoprotheses.

BACKGROUND

Endoprostheses are valuable tools for improving and saving lives. Inmany instances, an endoprosthesis is inserted into a vasculature in an“undeployed” state and must be expanded into a “deployed” state. Totransition the endoprosthesis between these two states, a balloon may belocated within the endoprosthesis in its undeployed state and inflated,with the expansion of the balloon pushing the endoprosthesis into itsdeployed state. However, in many instances the balloon extends beyondthe longitudinal length of the endoprosthesis. As a result, thoseportions of the balloon unconstrained by the endoprosthesis expandrapidly in comparison to those portions of the balloon within theendoprosthesis, causing the balloon to exert a longitudinal force on theendoprosthesis that causes the endoprosthesis to diminish inlongitudinal length. Aspects of the present disclosure reduce thateffect in order to create an improved endoprosthesis, among otherfeatures and benefits discussed below in more detail.

SUMMARY OF THE DISCLOSURE

In one embodiment, a medical device, comprises a stent-graft defining afirst free end, a second free end, and an intermediate portion betweenthe first and second free ends, the stent-graft having an undeployedstate with an undeployed diameter and an undeployed longitudinal lengthbetween the first free end and the second free end and a deployed statewith a deployed diameter and a deployed longitudinal length between thefirst free end and the second free end. The stent-graft includes a stentportion and a graft portion. The medical device further comprises acatheter assembly onto which the stent-graft is assembled in theundeployed state. The catheter assembly includes a balloon and a coverconcentrically surrounding the balloon. The intermediate portion of thestent-graft imparts a resistance to expansion of the balloon at theintermediate portion of the stent-graft and the cover also imparts aresistance to expansion of the balloon to reduce a difference in anexpansion rate of the balloon at the free ends of the stent-graftrelative to an expansion rate of the balloon at the intermediate portionof the stent-graft so as to reduce longitudinal compression of thestent-graft as the balloon expands the stent-graft from its undeployedstate to its deployed state.

In one variation, the deployed length of the stent-graft is at least 85%of the undeployed length of the stent-graft.

In one variation, the cover includes reinforcing portions configured toresist inflation of corresponding shoulder portions of the balloon so asto reduce longitudinal compression of the stent-graft as the balloonexpands the stent-graft from its undeployed state to its deployed state.

In one variation, the stent portion of the stent graft includes aplurality of ring stent elements that are separate components connectedby the graft portion of the stent-graft.

In one variation, the graft portion is configured to store longitudinallength of the stent-graft when the stent-graft is in the undeployedstate.

In one variation, the graft portion of the stent-graft is formed ofePTFE.

In another embodiment, a medical device comprises a stent-graft defininga first free end, a second free end, and an intermediate portion betweenthe first and second free ends, the stent-graft having an undeployedstate with undeployed longitudinal length between the first free end andthe second free end and a deployed state with a deployed longitudinallength between the first free end and the second free end. Thestent-graft includes a stent portion, and a graft portion. The catheterassembly, onto which the stent-graft is assembled in the undeployedstate, includes a balloon and a cover concentrically surrounding theballoon, the intermediate portion of the stent-graft imparting aresistance to expansion of the balloon at the intermediate portion ofthe stent-graft and the cover also imparting a resistance to expansionof the balloon such that the deployed length of the stent-graft is atleast 85% of the undeployed length of the stent-graft.

In one variation, the graft portion of the stent-graft is formed ofePTFE.

In one embodiment, a medical device comprises a stent-graft including:an inner ePTFE graft element, an outer ePTFE graft element, and amultiplicity of ringed stent elements positioned between the inner ePTFEgraft element and the outer ePTFE graft element, the stent-graft havingan undeployed state with a undeployed diameter and a deployed state witha deployed diameter greater than the undeployed diameter; and a catheterassembly including a balloon concentrically surrounded by a cover, thecover including reinforcing portions configured to resist inflation ofcorresponding shoulder portions of the balloon so as to reducelongitudinal compression of the stent-graft as the balloon expands thestent-graft from its undeployed state to its deployed state.

In one variation, the reinforcing portions of the cover maintain anexpansion profile of the balloon that diminishes an amount of radialexpansion of the shoulder portions of the balloon relative to a middleportion of the balloon as the balloon is inflated.

In one variation, the multiplicity of ringed stent elements areconfigured to store longitudinal length when the stent-graft is in theundeployed state.

In one variation, the stent-graft has an undeployed length in theundeployed state and a deployed length in the deployed state, whereinthe deployed length is between 85% and 99% of the undeployed length.

In one variation, the deployed diameter is about 10 mm, and wherein thestent-graft is sufficiently flexible to withstand a bend radius of lessthan about 8 mm without kinking when in the deployed state.

In one variation, the deployed diameter is about 10 mm, and wherein thestent-graft has a radial strength of between about 11 psi and about 12psi when in the deployed state.

In one variation, at least one ringed stent element is spaced apartbetween about 0.5 mm and about 2.0 mm from an adjacent ringed stentelement when the stent-graft is in the deployed state.

In one variation, the at least one ringed stent element is spaced apartbetween about 0.0 mm and about 0.2 mm from the adjacent ringed stentelement when the stent-graft is in the undeployed state.

In one variation, the multiplicity of ringed stent elements compriseinterconnected wire frames.

In one variation, an internal angle of one of the interconnected wireframes is about 90 degrees when the stent-graft is in the deployedstate.

In one variation, the multiplicity of ringed stent elements comprise asingle row of interconnected diamond shaped wire frames.

In one variation, the multiplicity of ringed stent elements comprisestainless steel.

In one variation, an apex of a first ringed stent element is out ofphase with an adjacent apex of a second ringed stent element along alongitudinal axis.

In another embodiment, a medical device comprises a stent-graft havingan undeployed state with an undeployed diameter and an undeployedlength, and a deployed state with a deployed diameter and a deployedlength, the stent-graft including: an inner graft element; an outergraft element; and a plurality of ringed stent elements positionedbetween and attached to the inner graft element and the outer graftelement; and a catheter assembly including: a balloon having acone-shaped end; a cover concentrically surrounding the balloon, thecover having a middle portion and a reinforcing portion concentricallysurrounding the cone-shaped end of the balloon, the reinforcing portionof the cover having a higher density than a density of the middleportion of the cover in order to maintain an expansion profile thatreduces longitudinal compression of the graft-stent.

In one variation, a spacing of at least some of the plurality of ringedstent elements when the stent-graft is in its undeployed state storeslongitudinal length that is recovered by the stent-graft in its deployedstate.

In one variation, the deployed length exhibits less than 1%foreshortening compared to the undeployed length.

In one variation, the stent-graft is compacted onto the cover so as toresist movement of the stent-graft relative to the balloon prior todeployment.

In one variation, the reinforcing portion of the cover has a radialstrength that is greater than a radial strength of the middle portion.

In one variation, the outer graft element includes an outer surfacecomprising ePTFE in contact with an inner surface of the cover, andwherein the inner surface of the cover comprises ePTFE.

In one variation, the balloon comprises nylon.

In one variation, a luminal surface of the inner graft element comprisesan antithrombogenic coating.

In one variation, the reinforcing portion of the cover restrictsexpansion of the cone-shaped end of the balloon during inflation of theballoon.

In one variation, the reinforcing portion of the cover includes anaxially compressed portion of the cover.

In one variation, the reinforcing portion of the cover includes apleated portion of the cover.

In one variation, pleatings in the pleated portion of the covercorrespond to pleatings in a pleated portion of the balloon.

In another embodiment, a method of making an stent-graft comprises:placing a plurality of ringed stent elements along a longitudinal axisand between an inner graft element and outer graft element; compressingthe plurality of ringed stent elements, the inner graft element, and theouter graft element into a compressed configuration; and moving at leasttwo of the plurality of ringed stent elements closer together to storelongitudinal length so that when the stent-graft expands into a deployedconfiguration, the stored longitudinal length is recovered.

In another embodiment, a method of making a deployment system comprisesassembling a stent graft to a deployment device, the stent-graft havinga first free end, a second free end, an intermediate portion between thefirst and second free ends, and a first diameter in an undeployed stateand the deployment device having a balloon and a cover surrounding theballoon, the stent-graft assembled to the deployment device such thatthe stent-graft surrounds the cover and the balloon, the intermediateportion of the stent-graft imparting a resistance to expansion of theballoon and the cover also imparting a resistance to expansion of theballoon to reduce a difference in an expansion rate of the balloon atthe intermediate portion of the stent-graft relative to an expansionrate of the balloon at the first and second free ends of the stent-graftso as to reduce longitudinal compression of the stent-graft uponexpansion of the balloon to transition the stent-graft from theundeployed state to the deployed state.

In one variation, moving the at least two of the plurality of ringedstent elements closer together comprises moving the at least two of theplurality of ringed stent elements from a separation distance of betweenabout 0.5 mm and about 2.0 mm to a separation distance of between about0.0 mm and about 0.2 mm.

In one variation, the method further includes placing a cover over aballoon, the cover having at least one reinforcing portion overlaying ashoulder of the balloon, the at least one reinforcing portion providingincreased resistance to inflation relative to a middle portion of thecover; and placing the stent-graft over the middle portion of the cover,such that the reinforcing portion of the cover reduces longitudinalcompressing forces exerted on the stent-graft during inflation of theballoon.

In one variation, the stent-graft exhibits greater than 99% longitudinalefficiency when the stent-graft expands from the compressedconfiguration into a deployed configuration.

In another embodiment, a method for treating a patient includes:inserting a stent-graft into a vessel of the patient, the stent-grafthaving a first length and a first diameter, the stent-graft surroundinga middle portion of a cover that concentrically surrounds a balloon, thecover and the balloon each having a length that is greater than thefirst length of the stent-graft such that at least one shoulder of theballoon and a corresponding portion of the cover are outside of thestent-graft, the corresponding portion of the cover being reinforced toprovide greater resistance to inflation of the shoulder of the balloonthan a middle portion of the cover provides to a middle portion of theballoon; and applying a pressure to the balloon to expand thestent-graft to a second diameter that is greater than the first diameterand to expand the stent-graft to a second length, the reinforced portionof the cover restricting inflation of the shoulder of the balloon tolimit longitudinal compressing forces on the stent-graft.

In one variation, the second length of the stent-graft is at least 85%of the first length of the stent-graft.

In one variation, the reinforcing portion of the cover includesscrunched portions of the cover.

In one variation, the reinforcing portion of the cover includes pleatedportions of the cover.

In one variation, pleatings in the pleated portions of the covercorrespond to pleatings in pleated portions of the balloon.

In another embodiment, a method for treating a patient includes:inserting a stent-graft into a vessel of the patient, the stent-grafthaving a first length and a first diameter, the stent-graft surroundinga cover that surrounds a balloon, the stent-graft including a pluralityof stent elements that are positioned to store longitudinal length; andapplying a pressure to the balloon to expand the stent-graft to a seconddiameter that is greater than the first diameter and a second length,wherein expanding the stent-graft recovers the stored longitudinallength.

In one variation, the second length of the stent-graft is between 85%and 99% of the first length of the stent-graft.

In one variation, the second length of the stent-graft is at least 85%of the first length of the stent-graft.

In one variation, the second length of the stent-graft is at least 99%of the first length of the stent-graft.

In another embodiment, a method for treating a patient includes:inserting a stent-graft into a vessel of the patient, the stent-grafthaving a first free end, a second free end, an intermediate portionbetween the first and second free ends, and a first diameter, thestent-graft surrounding a cover that surrounds a balloon, thestent-graft including a plurality of stent elements; and applying apressure to the balloon to expand the stent-graft from an undeployedstate to a deployed state having a second diameter that is greater thanthe first diameter, the intermediate portion of the stent-graftresisting expansion of the balloon and the cover also resistingexpansion of the balloon to reduce a difference in an expansion rate ofthe balloon at the intermediate portion of the stent-graft relative toan expansion rate of the balloon at the first and second free ends ofthe stent-graft so as to reduce longitudinal compression of thestent-graft as the balloon expands the stent-graft from the undeployedstate to the deployed state.

In one variation, the second length of the stent-graft is between 85%and 99% of the first length of the stent-graft.

In one variation, the stent-graft defines a first length in theundeployed state and a second length in the deployed state that is atleast 85% of first length.

In one variation, the stent-graft defines a first length in theundeployed state and a second length in the deployed state that is atleast 99% of first length.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present disclosure will become moreapparent from the detailed description set forth below when taken inconjunction with the drawings, wherein:

FIGS. 1A and 1B illustrate side views of an endoprosthesis in accordancewith embodiments of the present disclosure;

FIGS. 2A and 2B illustrate a side view and a partial cross section of anendoprosthesis delivery system in accordance with embodiments of thepresent disclosure;

FIG. 3 illustrates a perspective view of a medical device deliverysystem in accordance with embodiments of the present disclosure;

FIGS. 4A and 4B illustrate a cross sectional view of an undeployedballoon and cover and a cross sectional view of a deployed balloon,cover, and endoprosthesis, respectively, in accordance with embodimentsof the present disclosure; and

FIGS. 5A-5F illustrate side views of an endoprosthesis delivery systemin accordance with embodiments of the present disclosure in variousstages of deployment.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatuses configured to perform the intended functions. Stateddifferently, other methods and apparatuses can be incorporated herein toperform the intended functions. It should also be noted that theaccompanying drawing figures referred to herein are not all drawn toscale, but may be exaggerated to illustrate various aspects of thepresent disclosure, and in that regard, the drawing figures should notbe construed as limiting. Finally, although the present disclosure maybe described in connection with various principles and beliefs, thepresent disclosure should not be bound by theory.

The terms “endoprosthetic device,” “endoprosthesis,” “vascular device,”and the like can refer, throughout the specification and in the claims,to any medical device capable of being implanted and/or deployed withina body lumen. In various embodiments, an endoprosthesis can comprise astent, a stent-graft, a graft, a filter, an occluder, a balloon, a lead,and energy transmission device, a deployable patch, an indwellingcatheter, and the like.

In addition, throughout this specification and claims, the deliverysystems described herein can, in general, include an endoprosthesisconstrained by a “covering member” or “sheath.” The covering member orsheath can, in various embodiments, comprise a sheet of material that isfitted about an endoprosthesis. As used throughout the specification andin the claims, the term “elongate member” can refer to a shaft-likestructure such as a catheter, guidewire, introducer sheath, or the like.In various embodiments, an endoprosthesis can be mounted or loaded on acatheter, also referred to herein as an inner shaft, and, in aconstrained diameter, fit within an introducer sheath, also referred toherein as an outer shaft.

Further, the term “distal” refers to a relative location that is fartherfrom a location in the body at which the medical device was introduced.Similarly, the term “distally” refers to a direction away from alocation in the body at which the medical device was introduced.

The term “proximal” refers to a relative location that is closer to thelocation in the body at which the medical device was introduced.Similarly, the term “proximally” refers to a direction towards alocation in the body at which the medical device was introduced.

With continuing regard to the terms proximal and distal, this disclosureshould not be narrowly construed with respect to these terms. Rather,the devices and methods described herein may be altered and/or adjustedrelative to the anatomy of a patient.

As used herein, the term “constrain” may mean (i) to limit expansion,occurring either through self-expansion or expansion assisted by adevice, of the diameter of an expandable implant, or (ii) to cover orsurround, but not otherwise restrain, an expandable implant (e.g., forstorage or biocompatibility reasons and/or to provide protection to theexpandable implant and/or the vasculature).

As used herein, the term “vessel” refers to any luminal or tubularstructure within the body to which these constructs can be utilized.This includes, but is not limited to, vascular blood vessels, vasculardefects such as arteriovenous malformations, aneurysm, or others,vessels of the lymphatic system, esophagus, intestinal anatomy, sinuouscavity, urogenital system, or other such systems or anatomical features.Embodiments of the present invention are also suitable for the treatmentof a malignant disease (e.g., cancer) within or associated with avessel.

With initial reference to FIGS. 1A and 1B, an endoprosthesis 100 isillustrated. Endoprosthesis 100 may comprise, for example, an expandablestent-graft. In various embodiments, endoprosthesis 100 comprises aballoon expandable stent-graft. Although endoprosthesis 100 will beherein described as a balloon expandable stent-graft, endoprosthesis 100may comprise other implantable, expandable medical devices, including aself-expandable stent-graft.

In various embodiments, stent-graft 100 comprises a stent member 102.For example, stent member 102 can comprise one or more ringed stentelements 104. As will be discussed in greater detail, ringed stentelements 104 can be positioned adjacent to one another along alongitudinal axis 192 of stent-graft 100. In various embodiments, ringedstent elements 104 are evenly spaced from each other (i.e., uniformlydistributed along the longitudinal axis). In other embodiments, one ormore ringed stent elements 104 can be spaced apart from one another atdifferent spacing along longitudinal axis 192 (i.e., non-uniformlydistributed along the longitudinal axis). Any arrangement of ringedstent elements 104 is within the scope of the present disclosure.

Ringed stent elements 104 can comprise, for example, interconnected wireframes 106 arranged in a circular pattern. For example, ringed stentelements 104 can comprise a single row of interconnected wire frames106. One or more points 118 of a wire frame 106 can be in contact withand connected to points 118 of adjacent wire frames 106. In variousembodiments, ringed stent elements 104 can comprise a multiplicity ofindividual wire frames 106 formed independently of one another andconnected to each other at one or more points 118. In other embodiments,wire frames 106 are formed together as a single interconnected stentelement 104.

In various embodiments, ringed stent elements 104 can vary from eachother in stiffness. For example, one or more ringed stent elements 104having an increased stiffness can be located at a distal and/or proximalend of stent-graft 100. Further, one or more ringed stent elements 104having reduced stiffness can be located away from a distal and/orproximal end of stent-graft 100. Any combination of ringed stentelements 104, including multiple elements comprising different stiffnessfrom each other, is within the scope of the present disclosure.

Wire frames 106 can comprise a polygon, such as, for example, aparallelogram. In various embodiments, wire frames 106 comprise adiamond shape. In other embodiments, wire frames 106 can comprise asquare or rectangular shape. Any shape of wire frames 106, includingshapes that are not polygonal (such as ovoid or rounded shapes) orshapes that include undulations or bends, are within the scope of thepresent disclosure.

In various embodiments, wire frames 106 comprise a metal material. Forexample, wire frames 106 can comprise a steel, such as stainless steelor other alloy. In other embodiments, wire frames 106 can comprise ashape memory alloy, such as, for example, Nitinol. In yet otherembodiments, wire frames 106 comprise a non-metallic material, such as apolymeric material. Further, the material of wire frames 106 can bepermanent (i.e., non-bioabsorbable) or bioabsorbable. Any material ofwire frames 106 having sufficient strength is within the scope of thepresent disclosure.

For example, ringed stent elements 104 can, for example, be cut from asingle metallic tube. In various embodiments, ringed stent elements 104are laser cut from a stainless steel tube. However, any manner offorming ringed stent elements 104 and/or wire frames 106 is within thescope of the present disclosure.

Endoprosthesis 100 can further comprise a graft member 114. Graft member114 may, for example, provide a lumen through which blood may flow fromone end to another. Further, as will be discussed in greater detail,graft member 114 can comprise a number of layers or elements securedtogether to form a single graft member 114.

Graft member 114 can comprise, for example, an inner graft element 108.In various embodiments, stent member 102 is positioned concentricallyaround inner graft element 108. For example, inner graft element 108 cancomprise a layer of polymeric material having a luminal surface 110 thatis in contact with blood flow within a vessel. Stent member 102 cansurround, be in contact with, and provide support to inner graft element108.

In various embodiments, inner graft element 108 comprises a polymericmembrane capable of providing a bypass route to avoid vessel damage orabnormalities, such as aneurysms. Inner graft element 108 can comprise,for example, expanded polytetrafluoroethylene (ePTFE), polyester,polyurethane, fluoropolymers, such as perfluoroelastomers and the like,polytetrafluoroethylene, silicones, urethanes, ultra-high molecularweight polyethylene, aramid fibers, and combinations thereof. Otherembodiments for a graft member material can include high strengthpolymer fibers such as ultra-high molecular weight polyethylene fibers(e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g.,Technora®, etc.). Any graft member that is capable of providing a lumenfor fluid flow within the body of a patient is within the scope of thepresent disclosure.

Inner graft element 108 can comprise, for example, one or more layers ofa polymeric material. In various embodiments, inner graft element 108comprises a polymeric material continuously wrapped over a substrate ormandrel to form a generally tubular member. For example, inner graftelement 108 can be constructed with circumferential-, helical-, oraxial-orientations of the polymeric material. “Orientations,” as usedherein, generally refers to a directional property of a component ormaterial (e.g., the polymetric material) often with reference to thelongitudinal axis 192. Orientations may also be used to refer todirectional properties of certain features, such as, for example,orientations of the strength of the material.

In the embodiments discussed above, the polymeric material can bewrapped generally perpendicular to the longitudinal axis of the mandrelor substrate, i.e., circumferentially wrapped. In other embodiments, thematerial can be wrapped at an angle between greater than 0 degrees andless than 90 degrees relative to the longitudinal axis of the mandrel orsubstrate, i.e., helically wrapped. In yet other embodiments, thepolymeric material can be wrapped generally parallel to the longitudinalaxis of the mandrel or substrate, i.e., axially (or longitudinally)wrapped.

In various embodiments, inner graft element 108 may comprise a coatingon luminal surface 110. For example, a therapeutic agent such asantithrombogenic coating may be applied to luminal surface 110. Invarious embodiments, a heparin coating is applied to luminal surface110.

Graft member 114 can further comprise, for example, an outer graftelement 112. In various embodiments, outer graft element 112concentrically surrounds at least a portion of stent member 102. Forexample, outer graft element 112 can concentrically surround stentmember 102 and inner graft element 108, essentially sandwiching ringedstent elements 104 of stent member 102 between the two graft elements108 and 112.

Similarly to inner graft element 108, outer graft element 112 cancomprise, for example, expanded polytetrafluoroethylene (ePTFE),polyester, polyurethane, fluoropolymers, such as perfluoroelastomers andthe like, polytetrafluoroethylene, silicones, urethanes, ultra-highmolecular weight polyethylene, aramid fibers, and combinations thereof.Outer graft element 112 can include high strength polymer fibers such asultra-high molecular weight polyethylene fibers (e.g., Spectra®, DyneemaPurity®, etc.) or aramid fibers (e.g., Technora®, etc.). Further, outergraft element 112 can comprise one or more layers of polymeric material,and may be a tube or a wrapped element as described in connection withinner graft element 108. In various embodiments, inner graft element 108and outer graft element 112 comprise the same polymeric material. Inother embodiments, inner graft element 108 and outer graft element 112comprise different polymeric materials.

In such embodiments, inner graft element 108 and outer graft element 112can orient and maintain the position of each of a multiplicity of ringedstent element 104. For example, each ringed stent element 104 of stentmember 102 can be positioned at a desired location along inner graftelement 108 and then surrounded by outer graft element 112. In variousembodiments, after ringed stent elements 104 are properly positionedalong inner graft element 108, inner graft element 108 and outer graftelement 112 are bonded together. For example, heat can be applied tobond inner graft element 108 and outer graft element 112 together,thereby maintaining the position of ringed stent elements 104 withrespect to graft member 114.

In various embodiments, ringed stent elements 104 are spaced apart at adesired distance from each other. For example, each of ringed stentelement 104 can be positioned at between about 0 mm (i.e., one ringedstent element 104 abutting another) and about 4 mm apart from eachother. In various embodiments, each of ringed stent element 104 can bebetween about 1.0 mm and about 2.0 mm apart from each other, and inparticular embodiments are between about 1.1 mm and 1.5 mm from eachother. Although described with reference to specific embodiments, ringedstent elements 104 of stent member 102 can be spaced any distance apart,including multiple different spacings within the same stent member 102.

Further, in embodiments in which stent member 102 comprises spaced apartringed stent element 104, stent-graft 100 can comprise one or moreintra-ring graft segments 120. For example, intra-ring graft segments120 can comprise the portion of inner graft element 108 and outer graftelement 112 located between adjacent ringed stent element 104. As willbe discussed further, the properties of intra-ring graft segments 120,including the length of segments 120, can be manipulated to providedesired properties to stent-graft 100.

In various embodiments, a first ringed stent element 106 a comprises afirst apex 120 a and a second ringed stent element 106 b comprises asecond apex 120 b. First apex 120 a and second apex 120 b can beadjacent to each other. For example, first ringed stent element 106 aand second ringed stent element 106 b can be oriented with respect toeach other such that first apex 120 a and second apex 120 b are in acommon plane 190 orthogonal to a longitudinal axis 192. Stated anotherway, first apex 120 a and second apex 120 b are in phase with eachother. In other embodiments, first apex 120 a and second apex 120 b arenot in a common plane orthogonal to longitudinal axis 192 (i.e., apices120 a and 120 b are out of phase, or are otherwise not coplanar witheach other). Although described with reference to specific embodiments,any orientation of ringed stent elements 104, including multipledifferent orientations with the same medical device (i.e., stent-graft)is within the scope of the present disclosure.

Stent-graft 100 can be delivered to and deployed within a treatment areaof a patient. For example, with initial reference to FIGS. 2A and 2B,stent-graft 100 can be prepared and mounted to a catheter assembly 260comprising a catheter tube 262 with a continuous lumen 264. A cover 266can coaxially surround a balloon 268, which is coupled to catheter tube262 and continuous lumen 264 at or near the distal end of catheter tube262. Attachment of cover 266 to catheter tube 262 can be accomplished invarious ways, including adhering the proximal and distal ends of cover266 to catheter tube 262 using an adhesive, such as, for example, acyanoacrylate adhesive. Further, polymeric tape and/or film may be usedto secure the proximal and distal ends of cover 266 to catheter tube262.

Balloon 268 can comprise, for example a generally tubular shaped ballooncapable of inflating within the vasculature of a patient uponpressurization. For example, a biocompatible fluid, such as, forexample, water or saline, can be introduced into catheter tube 262, passthrough continuous lumen 264 and through an inflation port (not shown)in catheter tube 262 located at the interior of balloon 268, andpressurize balloon 268. As pressure to balloon 268 is increased, thediameter of balloon 268 is also increased.

Balloon 268 can comprise, for example, a non-compliant, generallyinelastic balloon. In such embodiments, balloon 268 can comprise amaterial that is configured to allow balloon 268 to expand to a chosendiameter upon sufficient pressurization and remain at or near the chosendiameter under further pressurization until a burst pressure is reached,such as, for example, nylon, polyethylene, polyethylene terephthalate(PET), polycaprolactam, polyesters, polyethers, polyamides,polyurethanes, polyimides, ABS copolymers, polyester/poly-ether blockcopolymers, ionomer resins, liquid crystal polymers and rigid rodpolymers.

In various embodiments, balloon 268 can comprise a compliant, relativelyelastic balloon. In such embodiments, balloon 268 can comprise amaterial that is configured to allow balloon 268 to continuouslyincrease in diameter as pressure to balloon 268 is increased, such as,for example polyurethanes, latex and elastomeric organosiliconepolymers, such as, polysiloxanes. When a distension limit is reached,balloon 268 can rupture.

In yet other embodiments, balloon 268 comprises a semi-compliantballoon. In such embodiments, balloon 268 behaves in a combination ofcompliant and non-compliant attributes. Although described in connectionwith compliant and non-compliant embodiments, any material orconfiguration that allows balloon 268 to inflate in a predictable mannerwithin the body of a patient, including in a combination of compliantand non-com pliant behavior, is within the scope of the presentdisclosure.

With reference to FIG. 3, in various embodiments, balloon 268 cancomprise a plurality of pleats 370. Pleats 370 can comprise, forexample, folds or inflection points in the material of balloon 268extending generally along at least a portion of longitudinal axis 192.In such embodiments, balloon 268 comprises a generally tubular shapehaving one or more pleats 370.

In various embodiments, balloon 268 can be coaxially surrounded by cover266. Cover 266 can comprise an inner surface that can substantiallyconform to an outer surface of balloon 268, such that both balloon 268and cover 266 comprise substantially the same shape, including whenballoon 268 is deflated. However, in other embodiments, cover 266 cancomprise a different shape or configuration from balloon 268.

In various embodiments, cover 266 can comprise a plurality of pleats372. Similarly to balloon 268, pleats 372 can comprise, for example,folds or inflection points in the material of cover 266 extendinggenerally along at least a portion of the longitudinal axis. In suchembodiments, cover 266 comprises a generally tubular shape having two ormore pleats 372. In various embodiments, cover 266 comprises the samenumber of pleats 372 as balloon 268. In various embodiments, along atleast a section of or the entire working length of balloon cover 266,the inner surface of balloon cover 266 interfaces with the outer surfaceof balloon 268 in both the pleated, collapsed configuration and theun-pleated, inflated configuration. In other words, and as shown in FIG.3, the pleated portions of the cover 266 substantially correspond intheir configurations to the corresponding pleated portions of theballoon 268, and the non-pleated portions of the cover 266 substantiallycorrespond in their configurations to the corresponding non-pleatedportions of the balloon 268.

Pleats 370 and 372 can be formed in cover 266 and balloon 268simultaneously. For example, balloon 268 can be coaxially surrounded bycover 266, and pleats 370 and 372 can then be formed in both balloon 268and cover 266, respectively.

In other embodiments, pleats 372 can be formed in cover 266 after pleats370 are formed in balloon 268. For example, a pre-pleated balloon 268can be coaxially surrounded by cover 266. In such embodiments, bothcover 266 and pre-pleated balloon 268 can be inflated together to aworking pressure, after which cover 266 and balloon 268 are subjected toa mechanical pleat forming process that can form, for example, the samenumber and configuration of pleats in cover 266 as in pre-pleatedballoon 268. While forming pleats 372 in cover 266, both cover 266 andballoon 268 can be deflated and compacted for delivery into the body ofa patient. Although described in specific embodiments, any manner offorming pleats in cover 266 is within the scope of the presentdisclosure.

In yet other embodiments, balloon 268 can comprise a plurality of pleats370 and cover 266 can comprise no pleats 372. In such embodiments,pleats 370 can be formed in balloon 268, followed by cover 266 beingplaced coaxially around the outer surface of balloon 268. Althoughdescribed in connection with specific examples (i.e., balloon 268 andcover 266 both comprising pleats, or only balloon 268 or cover 266comprising pleats), any configuration in which balloon 268 and/or cover266 comprises a plurality of pleats is within the scope of the presentdisclosure.

Cover 266 can comprise, for example, a polymer such as, for example,expanded fluoropolymers, such as, expanded polytetrafluoroethylene(ePTFE), modified (e.g., densified) ePTFE, and expanded copolymers ofPTFE. In various embodiments, the polymer can comprise a node and fibrilmicrostructure. In various embodiments, the polymer can be highlyfibrillated (i.e., a non-woven web of fused fibrils). Although describedin connection with specific polymers, any material or configuration thatallows cover 266 to inflate in a predictable manner within the body of apatient is within the scope of the present disclosure.

In various embodiments, cover 266 can comprise multiple layers of apolymeric material. For example, cover 266 can comprise a polymericmaterial continuously wrapped over a substrate or mandrel to form agenerally tubular member. In various embodiments, cover 266 can beconstructed with circumferential-, helical-, or axial-orientations ofthe polymeric material. In such embodiments, the polymeric material canbe wrapped generally perpendicular to the longitudinal axis of themandrel or substrate, i.e., circumferentially wrapped. In otherembodiments, the material can be wrapped at an angle between greaterthan 0 degrees and less than 90 degrees relative to the longitudinalaxis of the mandrel or substrate, i.e., helically wrapped. In yet otherembodiments, the polymeric material can be wrapped generally parallel tothe longitudinal axis of the mandrel or substrate, i.e., axially (orlongitudinally) wrapped.

With reference to FIG. 2B, cover 266 can, for example, have a length 282that is greater than a length 280 of balloon 268. In variousembodiments, cover 266 is placed around balloon 268 such that a firstcover end 270 and a second cover end 272 extend beyond a first balloonend 274 and second balloon end 276. In such embodiments, a segment 284of the material of cover 266 positioned at first cover end 270 or secondcover end 272 can be compressed along longitudinal axis 192 (i.e.,axially compressed). For example, with reference to FIGS. 4A and 4B,segment 284 of the material of cover 266 can be axially compressed(e.g., scrunched) at first cover end 270 and a segment 286 can beaxially compressed at second cover end 272.

As shown in FIGS. 4A and 4B, segment 284 and/or segment 286 are alignedwith a first balloon shoulder 290 and/or a second balloon shoulder 292.In other embodiments, the segments 284 and/or 286 are aligned withdifferent portions of the balloon 268. In FIGS. 4A and 4B, the firstballoon shoulder 290 and/or second balloon shoulder 292 are cone-shapedshoulders. Although described with reference to a specific embodiment,any shape of balloon shoulder is within the scope of the presentdisclosure.

Segment 284 can, for example, be positioned such that it at surrounds atleast a portion of first balloon shoulder 290, and segment 284 can bepositioned such that it at surrounds at least a portion of secondballoon shoulder 292. Providing additional axially compressed (e.g.,scrunched) material around balloon shoulders (such as balloon shoulders290 and 292) can increase the thickness and/or density of cover 266 inthe general area of the balloon shoulders. Furthermore, havingadditional axially compressed material of the cover 266 over the balloonshoulders allows for radial expansion of balloon 268 while limitingaxial compression to the balloon during inflation. For example, withouthaving those compressed portions, the shoulders of the balloon willinflate before the body of the balloon and cause axial compression ofthe balloon and endoprosthesis. But with the axially compressedmaterial, the shoulders of the balloon can expand in a manner thatcauses less axial compression of the endoprosthesis (e.g., due to thechanged angle between the expanded portion of the balloon and theunexpanded or less expanded portion of the balloon) until the pressurewithin the balloon as a whole is sufficient to more fully expand thecover and the endoprosthesis surrounding the body of the balloon.Further, increased thickness and/or density in the general region ofballoon shoulders 290 and 292 can provide additional radial strength tothe balloon shoulders to achieve a similar effect.

As previously described above, the balloon 268 can be inflated byproviding pressurized fluid into balloon 268. FIGS. 5A-5F illustrate oneexample of the cover 266 restricting expansion of balloon 268 to onedesired inflation profile as the balloon 268 is inflated. Theintermediate portion 200 of the stent-graft 100 imparts a resistance toexpansion of the balloon 268 at the intermediate portion 20 of thestent-graft 100, as well as at, or proximate to, the free ends 196, 198.The cover 266 also imparts a resistance to expansion of the balloon toreduce a difference in an expansion rate of the balloon 268 at the freeends 196, 198 of the stent-graft 100 relative to an expansion rate ofthe balloon 268 at the intermediate portion 200 of the stent-graft 100so as to reduce longitudinal compression of the stent-graft 100 as theballoon 268 expands the stent-graft 100 from its undeployed state (FIG.5A) to its deployed state (FIG. 5F). In some embodiments, the cover 266acts to equalize the expansion rate of the balloon 268 at theintermediate portion 200 of the stent with the expansion rate of theballoon at, or proximate to the free ends 196, 198 (e.g., proximate orat the shoulders).

For example, in some embodiments axially compressed segments 284 and/or286 are configured to provide additional resistance to the expansion ofballoon shoulders 290 and 292, causing a middle portion 294 of balloon268 to inflate more readily than it would without such segments 284 and286, which limits the expansion of the balloon shoulders to more closelymatch the expansion of the middle portion 294 of the balloon 268.Axially compressed segments 284 and/or 286 can also substantially impedeinflation of balloon shoulder 290 and/or 292. In various embodiments,this has the effect of controlling the extent of balloon inflation inthese regions which, in turn, controls the expansion profile of balloon268 and/or stent-graft 100.

In various embodiments, the expansion of balloon 268 can be controlledby covered segments 284 and/or 286 in a manner that may reduceundesirable expansion characteristics of stent-graft 100. For example,covered segments 284 and/or 286 may reduce the degree of foreshorteningof stent-graft 100 during expansion. In particular, segments 284 and/or286 may be configured to force the balloon to into a specific inflationprofile in which axial forces resulting from inflating balloon shouldersare significantly reduced, for example, due to the diminished anglebetween the shoulder portions of the balloon and the middle portion ofthe balloon or the stent-graft. Further, covered segments 284 and/or 286may reduce or prevent stacking (e.g., reduction of spacing betweenringed stent elements 106 during expansion) of stent-graft 100.

With reference to FIGS. 2A and 2B, after balloon 268 is surrounded bycover 266, stent-graft 100 can be loaded on to balloon 268 and cover266. For example, stent-graft 100 can be positioned to concentricallysurround a portion of balloon 268 and cover 266. In various embodiments,once stent-graft 100 is properly positioned around balloon 268 and cover266, stent-graft 100 is radially compressed to an undeployed diameter242. For example, stent-graft 100 can be compacted to undeployeddiameter 242 to reduce the profile of stent-graft 100 duringimplantation within a treatment area. Further, stent-graft 100 can becompacted onto balloon 268 and cover 266 so as to resist movement of thestent-graft on balloon 268 prior to deployment.

In various embodiments, upon compaction, stent-graft 100 can imbeditself into cover 266. For example, by imbedding itself into cover 266,stent-graft 100 may exhibit improved stent retention. Such improvedstent retention may, for example, assist in maintaining properpositioning of stent-graft 100 relative to cover 266 and/or balloon 268during deployment to the treatment area of a patient.

Another way to limit any reduction in the length of the endoprosthesis(e.g., as measured between one free end 196 and the opposite free end198) between its compressed and expanded configurations is by alteringthe position and/or orientation of the ringed stent elements 104 of astent member 102. In particular, in some embodiments the position and/ororientation of one or more ringed stent elements 104 of stent member 102can be altered prior to compaction of stent-graft 100. For example, thedistance between two or more adjacent ringed stent element 104 may bereduced prior to compaction of stent-graft 100. For more particularexamples, one or more ringed stent elements 104 can be moved so thatthey are each less than about 1 mm apart from each other or even so thatthey are in contact with one another (i.e., spaced 0 mm apart from eachother).

In other embodiments, the position and/or orientation of ringed stentelements 104 may be altered after compaction of the stent-graft 100. Forexample, and with reference to FIG. 2A, stent-graft 100 has a lengththat can be changed by reducing the longitudinal spacing of two or moreringed stent element 104. Reducing the longitudinal spacing betweenadjacent ringed stent element 104 can, for example, create storedlongitudinal length that is recovered when the stent element 104 isexpanded into its deployed state. For example, stored longitudinallength may be defined as the length or segment of graft material ofintra-ring graft segments 120 axially compressed between adjacent ringedstent elements 104 which is retrieved (i.e., axially expanded) uponexpansion and deployment of stent-graft 100. The “undeployed length” ofthe stent-graft 100 generally refers to the stent-graft 100 in thecompressed state prior to delivery and the “deployed length” of thestent-graft 100 generally refers to the stent-graft 100 in the expandedstate. In some embodiments, changing the spacing of the ringed stentelements 104 creates a new length that may be referred to as theundeployed length (e.g., length 240 in FIG. 2A).

Stated another way, reducing the spacing between adjacent stent elements104 can axially compress or scrunch intra-ring graft segments 120. Bycreating stored length by axial compression, the outside diameter of thestent-graft 100 is not increased. By not increasing the diameter of thedevice while creating stored length, the transverse-cross section of thedevice remains minimal and thus does not adversely affect delivery ofthe stent-graft through the vasculature. At the same time, recovery ofthe stored length increases the ability of the stent-graft to reduce oroffset any loss of length, e.g., due to axial compression forces frominflating the balloon.

Upon delivery of stent-graft 100 to the treatment area of a patient,stent-graft 100 can be deployed. In various embodiments, stent-graft 100is deployed by inflating balloon 268 to a desired diameter, therebyincreasing the diameter of stent-graft 100 from an undeployed diameter242 to a deployed diameter 146. This process further increases thelength of the stent-graft from the undeployed length 240 to a deployedlength 148. After balloon 268 is sufficiently inflated, so that deployeddiameter 146 is achieved, balloon 268 can be deflated, allowing forremoval of catheter assembly 260 from the body of the patient.

Deployed length 148 can, for example, be less than undeployed length240. For example, deployed length 148 can be about 60% to about 95% ofundeployed length 240, and further, about 80% to about 90% of undeployedlength 240. Testing has shown that certain embodiments have achieveddeployed lengths 148 greater than 99% the undeployed length, thusdemonstrating a foreshortening length of less than 1%. The ability of astent-graft to achieve a high percentage of its undeployed length isalso referred to herein as longitudinal efficiency.

Expanding stent-graft 100 from the undeployed configuration to thedeployed configuration can also, for example, increase an internal angleof one or more wire frames 106 of ringed stent elements 104. Forexample, when stent-graft 100 is in the deployed configuration, internalangle 188 of wire frames 106 of ringed stent elements 104 can be betweenabout 70 and 110 degrees, and further, between about 80 and 100 degrees.

EXAMPLE 1 Bend Radius

Various stent-grafts in accordance with the present disclosure weretested to evaluate their flexibility in the deployed configuration.Specifically, the stent-grafts were tested to determine the bend radiusthat the stent-graft can accommodate without kinking and can recover itsoriginal size and shape after testing. Kinking occurs at the point atwhich the stent-graft exhibits a diameter reduction of greater than 50%,or where it cannot recover its original size and shape after testing.

The stent-grafts were tested according to ISO25539-2 (2009), sectionD.5.3.6, method A with the following exceptions: 1) testing was notperformed in a tube of the minimum nominal indicated vessel diameters orat maximum indicated vessel diameter, and 2) overlapped conditiontesting was not performed. The stent-grafts comprise stainless steelringed stent elements spaced apart at approximately 0.5 mm to 1.5 mmfrom each other. The stents were approximately 59 mm long. The inner andouter graft elements comprised ePTFE, and the stent-grafts were mountedon a nylon balloon surrounded by an ePTFE cover having scrunchedproximal and distal ends. The results of the bend radius testing aresummarized below in Table 1.

TABLE 1 Bend Nominal Radius (mm) Diameter (mm) 5 10 Mean 4 7 Maximum 4 8Minimum 4 6 Sample Size 10 10

EXAMPLE 2 Radial Strength

Various stent-grafts in accordance with the present disclosure weretested to evaluate their radial strength in the deployed configuration.Specifically, the stent-grafts were tested to determine the radialcompressive pressure at which the stent-grafts would becomeirrecoverably deformed.

The stent-grafts were tested according to ISO25539-2:2009, sectionD.5.3.4 with the following exceptions: 1) pressure was reported inpounds per square inch, and 2) testing was conducted until a 50%reduction in the nominal device diameter was achieved.

The stent-grafts comprise stainless steel ringed stent elements spacedapart at approximately 0.5 mm to 1.5 mm from each other. The stents wereapproximately 59 mm long. The inner and outer graft elements comprisedePTFE, and the stent-grafts were mounted on a nylon balloon surroundedby an ePTFE cover having scrunched proximal and distal ends. The resultsof the radial strength testing are summarized below in Table 2.

TABLE 2 Radial Nominal Strength (psi) Diameter (mm) 5 10 Mean 18.3 11.9Maximum 20.9 12.6 Minimum 14.4 11.2 Sample Size 8 8

While particular embodiments of the present invention have beenillustrated and described herein, the present invention should not belimited to such illustrations and descriptions. It should be apparentthat changes and modifications may be incorporated and embodied as partof the present invention within the scope of the following claims.

Numerous characteristics and advantages have been set forth in thepreceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications may be made, especially in matters of structure,materials, elements, components, shape, size, and arrangement of partsincluding combinations within the principles of the invention, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed is:
 1. A system comprising: a stent-graft comprising aplurality of ringed stent elements disposed along a longitudinal axisbetween an inner graft element and an outer graft element; a deliverydevice including a balloon assembly, the stent-graft being releasablysecured over the balloon assembly in a diametrically compactedconfiguration with at least two ringed stent elements of the pluralityof ringed stent elements moved closer together in a longitudinaldirection to store longitudinal length in the inner and outer graftelements between the at least two ringed stent elements such that uponexpanding the stent-graft with the balloon assembly toward a deployedconfiguration the stored longitudinal length is recovered and a distancebetween the at least two ringed stent elements is maintained.
 2. Thesystem of claim 1, wherein the distance between the at least two ringedstent elements is between 1 mm and 2 mm.
 3. The system of claim 1,wherein the at least two ringed stent elements each include an apex, andwherein the apices of each ringed stent element are positioned adjacentone another such that the two ringed stent elements are in phase.
 4. Thesystem of claim 1, wherein the system further comprises a plurality ofintra-ring graft elements positioned between various of the plurality ofringed stent elements.
 5. The system of claim 4, wherein the systemincludes a first intra-ring graft defined by a portion of the innergraft element and the outer graft element between the at least tworinged stent elements.
 6. The system of claim 1, wherein the inner graftmember and the outer graft member are composed of an expanded polymer.7. The system of claim 1, wherein each of the plurality of ringed stentelements are secured through a bonding between the inner graft elementand the outer graft element.
 8. The system of claim 1, wherein theballoon assembly includes a balloon, and wherein the delivery devicefurther comprises a cover positioned coaxially over the balloon.
 9. Thesystem of claim 8, wherein the balloon comprises a plurality of pleatsextending along at least a portion of the balloon.
 10. The system ofclaim 9, wherein the cover comprises a plurality of pleats extendingalong at least a portion of the cover, and wherein the plurality ofpleats of the balloon and the plurality of pleats of the cover includethe same amount of pleats.
 11. A system comprising: a stent-graftincluding, a plurality of ringed stent elements, and a graft construct,the plurality of ringed stent elements disposed along the graftconstruct; and a delivery device including a balloon assembly, thestent-graft being releasably secured over the balloon assembly in adiametrically compacted configuration with at least two ringed stentelements of the plurality of ringed stent elements moved closer togetherin a longitudinal direction to store longitudinal length in the innerand outer graft elements between the at least two ringed stent elementssuch that upon expanding the stent-graft with the balloon assemblytoward a deployed configuration the stored longitudinal length isrecovered and a distance between the at least two ringed stent elementsis maintained.
 12. The system of claim 11, wherein the distance betweenthe at least two ringed stent elements is between 1 mm and 2 mm.
 13. Thesystem of claim 11, wherein the at least two ringed stent elements eachinclude an apex, and wherein the apex of each ringed stent element arepositioned adjacent one another such that the two ringed stent elementsare in phase.
 14. The system of claim 11, wherein the system furthercomprises a plurality of intra-ring graft elements positioned betweenvarious of the plurality of ringed stent elements.
 15. The system ofclaim 14, wherein the system includes a first intra-ring graft definedby a portion of the inner graft element and the outer graft elementbetween the at least two ringed stent elements.
 16. The system of claim11, wherein the inner graft member and the outer graft member arecomposed of an expanded polymer.
 17. The system of claim 11, whereineach of the plurality of ringed stent elements are secured through abonding between the inner graft element and the outer graft element. 18.The system of claim 11, wherein the balloon assembly includes a balloon,and wherein the delivery device further comprises a cover positionedcoaxially over the balloon.
 19. The system of claim 18, wherein theballoon comprises a plurality of pleats extending along at least aportion of the balloon.
 20. The system of claim 18, wherein the covercomprises a plurality of pleats extending along at least a portion ofthe cover, and wherein the plurality of pleats of the balloon and theplurality of pleats of the cover include the same amount of pleats.